The present invention is directed to methods of and products for enabling the disinfecting or antiseptic protecting and substantially room temperature storing of normally dry bacterial-component-containing solid emulsions for pharmacological use with bleeding cuts, wounds, and abrasions and the like, being more particularly concerned with the rendering antiseptic during packaged or other storage of such dry solid emulsions of the type that start to melt, sublime or liquefy at somewhat higher than room temperature, (as of the order of the temperature of human or animal blood in living subjectsxe2x80x94about 98-100xc2x0 F.), upon being contacted by moisture, such as complexes of polyvinylpyrrolidone admixed with cinnamic alcohol and tannic acid, as described in U.S. Pat. Nos. 3,525,340 and 3,777,016 of Joseph G. Gilbert, and in U.S. Pat. No. 4,094,967 of the Allor Foundation, common assignee of the present invention.
In the first two of the above-referenced Gilbert patents, there is described a process of preparing such a solid emulsion complex of polyvinylpyrrolidone admixed with cinnamic alcohol and tannic acid (and with iodine admixed in the third patent), wherein the solid emulsion, as applied to a flexible or foam or other bandage substrate, or to a swab or in solid powder state, is applied to bleeding cuts (lacerations, wounds, etc.) and abrasions and the like, and commences melting or liquefying from the exterior surfaces at the elevated temperature of the blood upon contacting the bleeding cut or the like. This action releases the melting or liquefying active anti-bacterial cinnamic alcohol from the solid complex, and independently, active fungicidal tannic acid, that has been found remarkably to prevent infections, and, particularly through the film-forming and coagulation-binding of the polyvinylpyrrolidone, promotes rapid healing and, surprisingly, substantially without keloid formation.
Earlier culture tests demonstrating efficacy against pathological organisms, animal clinical tests, and substantial human subject clinical use are described particularly in the before-cited U.S. Pat. No. 3,777,016.
Because of the elevated-temperature-induced and/or moisture liquefying release and/or subliming by the blood in the wound of the bactericidal component (cinnamic alcohol) at the exterior surface of the solidified emulsion product upon use, it was thought that concerns about antiseptic packaging were no longer necessary. This had been considered a radically new feature of this novel product in that it did not have to be kept sterile or even packaged, because, substantially instantaneously upon use, the wound was immersed in released bacterial liquid melted from the solid emulsionxe2x80x94and, indeed, as stressed in the first two of the above patents, it was found no longer necessary, from an infection point of view, to be concerned even with careful cleansing of the skin at the wound area before applying the dressing.
In retrospect, however, this turned out to be too radical a concept for acceptance by the medical and health-care-providing community which had and has the ingrained concept of universal aseptic products and packaging whether really needed or not. The terms xe2x80x9cpackagingxe2x80x9d and xe2x80x9cpackagexe2x80x9d are herein generically used to embrace envelopes, wrappings and other containments or coverings.
But the nature of this type of heat and moisture meltable or liquefying solidified emulsion complex, unfortunately, did not tend itself to any of the conventional high temperature auto-cleaving, ethylene oxide treatment, extended ultra violet, or other aseptic packaging and storing techniques customarily used for other products, in view of the deleterious physical and chemical effects of such procedures upon such emulsions.
It was not until the discovery underlying the present invention, indeed, that an effective and inexpensive disinfecting or antiseptic packaging technique was finally evolved, that is particularly tailored to, and inherently self-generating with the heatxe2x80x94and moisture-meltable or liquefying characteristics of the room temperature dry solid emulsion products hereinvolved, requiring no autoclaves or similar conventional sterilizing technique treatments, and that now promises to make these products commercially acceptable in the health-care industry.
It is accordingly an object of the present invention to provide a new and improved method of rendering such bactericidal-component-containing solid emulsion complexes antiseptic along their exposed surfaces and/or within packages enclosing the same, and providing resulting novel antiseptic solid emulsions.
Other and further objects will be explained hereinafter and are more fully delineated in the appended claims.
In summary, from one of its important aspects, the invention embraces in the preparation of a normally room-temperature-stored package containing a normally dry bactericidal-component-dispersed solid emulsion complex (such as a cinnamic alcohol component, for example) for pharmacological use with bleeding cuts and abrasions and that remains solidified at room temperature and below and so long as it is not contacted by moisture, but that starts to liquefy at somewhat higher temperature of the order of the temperature of human or animal blood in a living subject upon application of moisture thereupon, a method of rendering antiseptic both the exposed surface of the solidified emulsion and the interior of the package, that comprises, treating the interior of the package with one or both of increased temperature, at least to said higher temperature, and applied moisture to said exposed surface, and, doing so only for a time interval that is limited to the time required for the commencement of liquefying of said component sufficiently to wet the exposed surface of the solidified emulsion from which the component is drawn, and with a concurrent resulting commencement of release of bactericidal vapor therefrom, and, returning the package to room temperature, and sealing the package from further moisture, to enable the drying and re-solidifying of the exposed surface of the emulsion after having been thus wetted with the bactericidal component liquid drawn therefrom, and with the interior of the package having been exposed to the released bactericidal vapor.
Preferred and best mode techniques, modifications and products will be described hereinafter in detail.